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Sponsors and Collaborators: |
UNC Lineberger Comprehensive Cancer Center National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00246753 |
RATIONALE: Lapatinib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth.
PURPOSE: This phase II trial is studying how well lapatinib works in treating patients with prostate cancer that did not respond to hormone therapy.
Condition | Intervention | Phase |
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Prostate Cancer |
Drug: lapatinib ditosylate Other: laboratory biomarker analysis |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Open Label |
Official Title: | A Phase II Study of Oral Once Daily GW572016 (Lapatinib) In Patients With Hormone Refractory Prostate Cancer |
Estimated Enrollment: | 24 |
Study Start Date: | October 2005 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter, open-label study.
Patients receive oral lapatinib ditosylate once daily. Treatment continues in the absence of disease progression or unacceptable toxicity.
Serum samples are collected for biomarker analysis at baseline and every 4 weeks.
After completion of study treatment, patients are followed at 4 weeks.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Hormone-refractory disease
Prior androgen-deprivation therapy (either bilateral orchiectomy or medical castration resulting in a testosterone level < 50 ng/dL) for prostate cancer required
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
At least 7 days since prior and no concurrent inhibitors of CYP3A4, including any of the following:
At least 14 days since prior and no concurrent inducers of CYP3A4, including any of the following:
Glucocorticoids (cortisone [> 50 mg], hydrocortisone [> 40 mg], prednisone [> 10 mg], methylprednisolone [> 8 mg], dexamethasone [> 1.5 mg])
United States, North Carolina | |
Duke Comprehensive Cancer Center | |
Durham, North Carolina, United States, 27710 | |
Lineberger Comprehensive Cancer Center at University of North Carolina - Chapel Hill | |
Chapel Hill, North Carolina, United States, 27599-7295 | |
Rex Cancer Center at Rex Hospital | |
Raleigh, North Carolina, United States, 27607 |
Principal Investigator: | Young Whang, MD, PhD | UNC Lineberger Comprehensive Cancer Center |
Study ID Numbers: | CDR0000550151, UNC-LCCC-0505 |
Study First Received: | October 28, 2005 |
Last Updated: | February 6, 2009 |
ClinicalTrials.gov Identifier: | NCT00246753 History of Changes |
Health Authority: | United States: Federal Government |
adenocarcinoma of the prostate recurrent prostate cancer stage I prostate cancer |
stage II prostate cancer stage III prostate cancer stage IV prostate cancer |
Prostatic Diseases Genital Neoplasms, Male Lapatinib Urogenital Neoplasms Genital Diseases, Male |
Adenocarcinoma Protein Kinase Inhibitors Hormones Prostatic Neoplasms Recurrence |
Genital Neoplasms, Male Prostatic Diseases Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Urogenital Neoplasms Lapatinib Enzyme Inhibitors |
Genital Diseases, Male Protein Kinase Inhibitors Pharmacologic Actions Neoplasms Neoplasms by Site Therapeutic Uses Prostatic Neoplasms |